GQL · Class II · 21 CFR 866.3305

FDA Product Code GQL: Antisera, Fluorescent, Herpesvirus Hominis 1,2

Leading manufacturers include Syva Co., Baxter Healthcare Corp and Diagnostic Products Corp..

37

Total

37

Cleared

123d

Avg days

1977

Since

FDA 510(k) Cleared Antisera, Fluorescent, Herpesvirus Hominis 1,2 Devices (Product Code GQL)

37 devices

1–24 of 37

Cleared Dec 13, 1990

PATHODX HERPES TYPING

Diagnostic Products Corp.

Microbiology · 93d

Cleared Jul 31, 1990

BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2

Baxter Healthcare Corp

Microbiology · 43d

Cleared Jul 31, 1990

BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST

Baxter Healthcare Corp

Microbiology · 43d

Cleared Mar 11, 1985

AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT

Microbiology · 24d

Cleared Jan 18, 1985

MICROTRAK HSV 1 & 2 DIRECT SPECIMAN

Microbiology · 303d

Cleared May 07, 1984

MICROTRAK HSV 1 & 2 CULTURE

Microbiology · 91d

Cleared Jun 22, 1983

MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION

Microbiology · 89d

About Product Code GQL - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,218 total devices indexed.

Latest clearance: Aug 28, 2009

Product Code Info

Code	GQL
Device class	Class II
CFR	21 CFR 866.3305
Panel	Microbiology

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